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upcoming FDA approval for HBsAG quantitative
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upcoming FDA approval for HBsAG quantitative

Thanks to everyone for the valuable information provided here. I've had Hep B for 8 yrs and on ent for 7 yrs. I sero converted to e-antigen negative after 7 months and DNA is undetectable. After reading about the S antigen quantitative test not being available in the US, I started emailing labs and doctors to see if anyone knew where to get this test done. One of the top liver specialists at Georgetown University Hospital in DC emailed that according to his sources, "several companies are due to have their HBsAG quantitative test approved by the FDA in the coming months and we may hear about it in the near future". From what I've read on this forum, I would assume Roche and Abbott would be the companies. So maybe some good news for those of us in the States.
9 Comments Post a Comment
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Avatar_m_tn
That is very good news. Hopefully it will also be available in Australia too.
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Avatar_m_tn
what gets measured gets fixed.  This is a good step forward.
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Avatar_m_tn
Step forward? How many years are they behind here with this test?
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Avatar_m_tn
I wanted just to comment on this post. We are now in 2015 and FDA didn't approve hbsag quantitative. Any news on when it will be approved?
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Avatar_m_tn
Any comments guys?
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Avatar_m_tn
Great news! Can't wait. Been exploring the sending blood to Mexico/India option with no luck. Didn't like the tenuous nature of the option.
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Avatar_m_tn
I contacted the liver specialist at Georgetown and he had no further info or reason for this still not being approved. Then I contacted Sen. Tim Kaine's office and asked if they could find out from the FDA when this would be approved. FDA gave a ridiculous answer that they couldn't even confirm if the test is under consideration for approval as it might give one company or another some type of financial advantage. Go figure.
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Avatar_m_tn
what.....they manage financial advantages and care about it more than health and are not ashamed to tell?
if it was my country i d burn down such a thing (i dont have words to describe it)
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Avatar_m_tn
Thank you jamesdc for following up on this as manybof us here in the states lack this test. I have to wait until december to do my test when i fly to germany.
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